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2 Hits

Jobs by e-mail

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    Reference number: 870024/1

    Program Lead US (m/f/d)

    Freelance/Contracting project
    Vienna and remote
    • End-to-end responsibility for a complex drug development program, including: Development, Regulatory approval, US launch, Market Access
    • Establishment of local structures and capabilities in the US (e.g. if the US becomes a new disease area, new organizational capabilities need to be built; this process must be coordinated and aligned within the overall program)
    • Overall program leadership across all phases
    • Leadership and coordination of cross-functional, international project teams (including teams and service providers across European and US time zones)
    • Management of external partners, service providers, and consultants
    • Close collaboration with Senior Management and Executive stakeholders
    • Preparation and presentation of decision-relevant materials at management level
    • Ensuring timeline, budget, and quality targets in a highly regulated environment
    • Program management and controlling
    • Proactive risk and scenario management (including the possibility of early project termination)
    Online since: Tue Apr 14 15:28:10 CEST 2026
    Reference number: 870033/1

    Strahlensterilisationsexpert (m/w/d)

    Freiberuflich für ein Projekt
    Hybrid
    • Beratung bei Problemstellungen im Ebeam Bereich Bearbeitung von Sterilisationsabweichungen im Zusammenhang mit Gamma oder E Beam Sterilisation, inklusive fundierter Ursachenanalyse
    • Durchführung von Validierungen und Revalidierungen gemäß ISO11137, insbesondere Dosisfestlegung, Dosisverifizierung und Definition geeigneter Worst Case Szenarien
    • Hands on Troubleshooting in laufenden Sterilisationsprozessen, z.B. bei Auffälligkeiten in Dosisverteilung, Beladungskonzepten oder biologischen Indikatoren
    • Bearbeitung nicht standardmäßiger Fragestellungen, etwa bei unerwarteten mikrobiologischen Ergebnissen oder instabilen Prozessen, mit Fokus auf nachhaltige Prozessverbesserung
    • Fachliche Abstimmung mit QA, Produktion und externen Dienstleistern zur Bewertung, Umsetzung und regulatorisch sauberen Absicherung der Maßnahmen
    Online since: Tue Apr 14 15:13:48 CEST 2026

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